Source: https://tendernation.io/opportunities/01a13c1d-fd48-729c-bde4-491d6e4cfa8c/service-contract-for-production-filling-isolator

pending GB open procedure Suitable for SMEs

# Service contract for production filling isolator

[Medicines and Healthcare Products Regulatory Agency](https://tendernation.io/buyers/medicines-and-healthcare-products-regulatory-agency)

Estimated value

Not stated

Published

18 Dec 2018

Deadline

Rolling deadline

## Who can bid

- Buyer says suitable for SMEs

    The buyer ticked “suitable for SMEs” on the notice. Anyone can still bid.
- Open procedure

    Anyone can submit a full tender; there is no shortlisting stage.

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## About this tender

Agency need a contract to provide annual service, calibration, repairs, modifications and supply of parts original manufacturer (Metall & Plastic) parts for its production filling isolator. We are under the impression that there is only one supplier which can provide the required service. Before we proceed further, I want to check, can you do this? For further details, please read the following text.

Description:

The Production isolator is part of a filling line for liquid or Freeze-dried products in screw-capped vials. The isolator houses a B&S filling machine and interfaces with a Serail Freeze dryer.

The inside of the isolator is designed to be sanitised with Formaldehyde after every run. There are two transfer isolators which are used to transfer equipment and filled vials from one end of the line to the other for the capping process. The isolator runs under negative pressure with HEPA filtration and CG-air distribution system, and has a refrigeration unit with heating and cooling from 4Â°C to 30Â°C.

Annual servicing to include but not limited to:

Visual inspection of CG-membranes - Replace, repair as necessary

Visual inspection of isolator lighting - Replace, repair as necessary

HEPA / ULPA integrity testing - Replace, repair as necessary

### Check and adjustment of pressure switches

Leak testing of gloves and half-suit - Replace, repair as necessary

Leak testing of transfer isolators - Replace, repair as necessary

Leak testing of pneumatic gaskets - Replace, repair as necessary

Leak testing of filling isolator without transfer isolators - Repair as necessary

Replace compressed air filter

### Replace PLC battery

Refrigeration unit Change filter & oil check system for leaks and operation.

Annual Calibration:

Pressure transmitters

### Flow sensors

### Temperature sensor

Relative humidity sensor

### Pressure gauges

Potential suppliers if they feel they can meet the requirement should email  to register an interest.

If no submissions of potential interest are received by close of play 08 January 2019, it is then intended to perform a direct award without competition to the sole supplier we believe can deliver the required service.

Read full description

## CPV classification

Medical equipments, pharmaceuticals and personal care products

Source

Contracts Finder (UK)

[View official notice](https://www.contractsfinder.service.gov.uk/notice/1dba5560-251f-49e9-8e72-cc63e81f751c)

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